FDA: Claris IV Medications Recalled Due to Contamination

Recall issued due to white foreign matter found in IV bags of metronidazole and ondasetron
By Beth Gilbert
HealthDay Reporter

TUESDAY, June 1 (HealthDay News) -- The U.S. Food and Drug Administration has notified health care professionals not to use intravenous medications including metronidazole, ciprofloxacin and ondansetron manufactured by Claris Lifesciences, as the products may be contaminated.

The FDA alerted health care professionals because of reports of white floating matter in the intravenous bags of metronidazole and ondansetron. Intravenous products that could potentially be affected include those sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels.

The Cladosporium mold was identified after microbiological analysis was performed due to a Claris customer receiving a complaint of white matter in a bag of metronidazole. In susceptible patients, this type of mold can cause infections. In addition, another bag of ondansetron is being investigated due to a complaint of white matter in an intravenous bag. The FDA recommends that these products not be used and immediately removed from pharmacy inventories.

"Claris is initiating a recall of all lots of these two products, as well as all lots of ciprofloxacin. These products were all manufactured on the same manufacturing line. FDA is investigating the situation and will notify the public when new information becomes available," according to a recent FDA public health alert.

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